A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients: impact on cardiovascular risk reduction.

Design: In this randomized multicenter study, 302 persons with hypertension and dyslipidemia (n =1 83) or with type 2 diabetes mellitus (n =1 19) were randomized to the nutrient-fortified prepared meal plan (approximately 22% energy from fat, 58% from carbohydrate, and 20% from protein) or to a macronutrientequivalent UCD. Main Outcome Measures: The primary outcome measure was weight change. Secondary measures were changes in blood pressure or plasma lipid, lipoprotein, glucose, or glycosylated hemoglobin levels; quality of life; nutrient intake; and dietary compliance. Results: After 1 year, weight change in the hypertension/ dyslipidemia group was ˛5.8±6.8 kg with the prepared meal plan vs ˛1.7±6.5 kg with the UCD plan (P,.001); for the type 2 diabetes mellitus group, the change was ˛3.0±5.4 kg with the prepared meal plan vs ˛1.0±3.8 kg with the UCD plan (P,.001) (data given as mean±SD). In both groups, both interventions improved blood pressure, total and low-density lipoprotein cholesterol levels, glycosylated hemoglobin level, and quality of life (P,.02); in the diabetic group, the glucose level was reduced (P,.001). Compared with those in the UCD group, participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total (P,.01) and high-density lipoprotein (P,.03) cholesterol levels, systolic blood pressure (P,.03), and glucose level (P,.03); in participants with type 2 diabetes mellitus, there were greater improvements in glucose (P=.046) and glycosylated hemoglobin (P,.02) levels. The prepared meal plan group also showed greater improvements in quality of life (P,.05) and compliance (P,.001) than the UCD group. Conclusions: Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients. The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular risk. Arch Intern Med. 2000;160:2150-2158